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in regulating toxics. The analytical tools are not sophisticated enough today to make that determination with confidence."
Meanwhile, as the EPA neared its deadline for approving the wood products regulation, the federal research institutes had updated two of the largest studies of formaldehyde toxicity ever conducted on human subjects. The National Cancer Institute study, published in November 2003, showed that 25,000 workers exposed to formaldehyde had an increased risk of leukemia.
A separate study of 10,000 workers by the National Institute of Occupational Safety and Health also found an elevated leukemia risk, but at different exposure levels. This assessment was posted on the institute's website in early 2004 and published in March.
Conversely, a third study of about 14,000 workers in England published in November 2003 found no such risk.
The authors of the U.S. studies said their work only suggested a link to leukemia, contained seemingly contradictory evidence and didn't explain how formaldehyde might trigger cancer in internal organs. But there was widespread agreement that the findings provided new reason for concern.
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Studies Back Old Level
An internal EPA calculation showed that taking the new studies into consideration would keep the formaldehyde risk assessment close to the long-standing EPA level. Some staffers contended the agency should wait before finalizing a rule.
As a practical matter, if the EPA went plant-by-plant using its old risk level, about 90 facilities could be exempt from formaldehyde controls. But if the lower chemical institute assessment were employed, an additional 57 plants could qualify for the exemption.
The Chemical Industry Institute of Toxicology, a private, nonprofit research organization, changed its name in 2000 to the CIIT Centers for Health Research. Chemical companies provide most of the institute's funding, although it also receives federal grants and industry contracts.
In an e-mail to colleagues, Peter W. Preuss, who directs the EPA's National Center for Environmental Assessment, said he had "never been comfortable" with the chemical institute formaldehyde risk number or with calling it the "best available science." He is overseeing EPA's own assessment of formaldehyde risk.
And the World Health Organization's cancer research agency had called a meeting for early June to consider the new leukemia findings.
California's Scientific Review Panel on Toxic Air Contaminants cited the upcoming leukemia studies in mid-2003 when it postponed an industry request to adopt a more permissive formaldehyde standard. After further review, the panel, which advises the state's Air Resources Board, voted 6-0 Wednesday to recommend against reopening its risk assessment.
Panel chairman John Froines determined the case for reconsideration, including the chemical institute model, was "not ready for prime time," a spokesman said. And a leading state toxicologist told the panel any reassessment should include the new cancer institute study.
In contrast, EPA leaders decided to complete the federal rule based on the chemical institute science. They said they felt compelled by the court order to sign the new rule by the end of February. Extensions are frequently granted, but EPA did not seek one.
If the EPA's evaluation of formaldehyde risk finds merit in the leukemia studies, administration officials say, the risk assessment could be readily revised. But legal and regulatory experts say the rule has so many untested provisions that such a change would invite lawsuits that could take years to resolve.
"The question is: Are you going to effectively throw away all the work that's been done … and say we always have to err on the side of any possible uncertainty?" Holmstead said. "At the end of the day, we have to make decisions based on the best available science."
Many scientists, regulatory law experts and environmentalists insist the EPA should have taken the new human research studies into account when it did its risk assessment. The industry and others counter that unresolved questions about the studies made it premature to use them as the basis for regulation.
"The public should not assume a cause-and-effect relationship when only an association is suggested," said Betsy
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